Chemicals

Chemical Prioritization and Evaluation Rules Issued by EPA

The EPA has finalized two rules required by the amended Toxic Substances Control Act (TSCA), which are intended to guide the Agency in both prioritizing chemicals for risk evaluations and actually conducting those evaluations.
Both rules apply only to the EPA, and the regulated community is not specifically affected. However, the outcome of prioritization and risk evaluation has major consequences for the commercial chemical sector as well as public health and environmental protection. Accordingly, the Agency wrote the rules in consideration of the many public comments on the proposed actions.

Both final rules were published in the July 20, 2017, Federal Register (FR).

Prioritization

The first rule meets the EPA’s obligation under TSCA section 6(b)(1) to establish a process for prioritizing chemicals for risk evaluations. The law directs that the Agency develop criteria by which it will identify chemical substances from a list of candidates as either high-priority substances for risk evaluation or low-priority substances for which risk evaluations are not warranted at the time.

The EPA notes that its policy objective in writing the rule is to produce a process that allows identification of chemicals that have the greatest hazard and exposure potential first. The process is not intended to depend on an exact scoring or ranking system. Neither does identification of high-priority chemicals depend wholly on how a specific chemical is used.

“The statute is clear that EPA is to designate the priority of the ‘chemical substance’—not a condition of use for a chemical substance,” says the Agency.

In terms of candidate selection, the EPA notes that the TSCA requires the Agency to give preference to chemical substances listed in the 2014 update of the TSCA Work Plan for Chemical Assessments, which are persistent and bioaccumulative; known human carcinogens; and/or highly toxic. The statute further requires that the Agency draw at least 50 percent of its candidates form the Work Plan. Apart from this statutory preference, TSCA does not specifically limit how the EPA must ultimately select a chemical substance to put into the prioritization process.

In response to requests from stakeholders, the EPA’s final rule includes a general objective for designating candidate chemicals as low-priority for risk evaluations consistent with the statutory definition for low-priority substances—“a chemical substance that EPA concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the standard for a high-priority substance.”

Also, in line with TSCA, the prioritization process will last between 9 and 12 months. The process officially begins when the EPA publishes a notice in the FR identifying a chemical substance for prioritization. Publication in the FR starts a 90-day public comment period.

Risk Evaluation

The second rule is the EPA’s response to TSCA section 6(b)(4). That section directs the Agency to establish a process to conduct risk evaluations to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use.”

TSCA also enumerates the deadlines and minimum requirements applicable to risk evaluation process, including provisions that direct which chemical substances must undergo evaluation, the development of criteria for manufacturer-requested evaluations, the minimum components of an Agency risk evaluation, and the timelines for public comment and completion of the risk evaluation. Further, the EPA must undertake the evaluations in a manner consistent with the best available science and make decisions based on the weight of evidence. Each of these elements is addressed in the final rule.

Other requirements that TSCA specifies must be included in the evaluation process and which are covered in the rule include the use of a specific framework to evaluate metals and metal compounds, and a provision to reduce testing on vertebrate animals.

The rule also includes several measures the EPA has added to the TSCA requirements, including adding direct references in the final rule to acknowledge the Agency’s commitment to implementing the best available science and weight of the scientific evidence provisions in TSCA; codifying the Agency’s commitment to interagency collaboration; allowing manufacturers to limit their requests for EPA-conducted risk evaluations to one or more specified conditions of use; and allowing for risk determinations to be made on individual conditions of use or categories of conditions of use at any time once the final scope (which specifies the conditions of use that EPA expects to consider in the risk evaluation) is published.

Connect with Us

Free Resources

Check out the results of BLR’s OSHA Recordkeeping Standard and Electronic Submission Survey sponsored by Sphera. The survey sheds light on how companies are faring in response to OSHA’s upcoming 1904 recordkeeping rule updates and what solutions are expected to help them with electronic submission. Highlighted findings from the poll of over 400 survey participants include […]

Check out our recent survey and its accompanying report, both sponsored by eCompliance®, to get insight into how safety professionals and their companies are encouraging employees to actively participate in safety initiatives. The study illustrates the diverse opinions within the safety field regarding such issues as implementing behavior-based vs. participation-based programs, measuring safety participation, and […]

The Supply Chain and Sustainability Survey sponsored by Avetta® was launched in mid-April 2017 and surveyed 379 environmental, health, and safety (EHS) professionals. Respondents shared their insights into how their companies are managing the safety risks that naturally occur in supply chains. Download the report today and see what our respondents had to say!

This survey and its companion report, sponsored by the American Heart Association, sought to understand how organizations are approaching First Aid, cardiopulmonary resuscitation (CPR), and automated external defibrillator (AED) training. We found out: The Importance of First Aid/CPR/AED training within companies The top reason for offering First Aid/CPR/AED training How employee’s reacted to this training […]

OSHA Challenge

On Monday, August 21, 2017, all of North America will be treated to an eclipse of the sun. The National Aeronautics and Space Administration (NASA) projects that the longest duration of the total eclipse of the sun will be near:

Safety Solutions Showcase

Safety Decisions Magazine

A quarterly magazine offering a fresh look at the strategic issues that challenge safety executives in today’s ever-changing business arena. Read the latest edition today.

Safety Training

Compliance will only take you so far with injury prevention. To achieve world-class safety performance on and off-the-job you must address the human factors that are involved in the majority of incidents and injuries. Learn how SafeStart fits within your existing safety system to reduce injuries 24/7